A resource for informing patients and caregivers about Multiple Sclerosis, its possible causes, effects, and treatments. Get the most current information on new developments, clinical trials and other important matters for anyone dealing with MS.

Tuesday, May 13, 2008

A decade-long, $3-million lawsuit about whether a minor injury can trigger or exacerbate the onset of multiple sclerosis has collapsed after the B.C. Supreme Court ruled the underlying theory is likely bogus.

After hearing from the world's foremost neurological authorities, Justice Austin Cullen concluded in a recent pretrial ruling that medical consensus no longer considers trauma to be a potential catalyst of the disease linked to the body's auto-immune system.

The lengthy and complicated decision abruptly ended this specific suit, involving the Insurance Corporation of B.C., but it also may halt lots of other outstanding litigation launched across the continent on similar grounds -- the now-debunked hypothesis put forward by renowned researcher Dr. Charles M. Poser.

From the Harvard Medical School and a senior neurologist with the Beth Israel Deaconess Medical Centre, Poser has been a leading figure in multiple sclerosis research for decades. He is broadly published and highly respected.

Yet in the legal community, many blame him for creating a "courtroom problem driven by medical hogwash."

Justice Cullen came down on their side. He pummeled the octogenarian doctor for giving at times contradictory evidence, misinterpreting medical studies and slanting his testimony.

"Dr. Poser, who was the primary witness for the plaintiff, testified as an advocate for a theory that once had currency but has since been eroded by the advance of scientific studies and knowledge," the justice wrote.

"I found in his evidence a tendency to overstate the implications of studies that he relied on, and to be unduly dismissive of those that undermined his theory. While he has clearly achieved the status of a foremost expert in his field of neurology, I find that his commitment to his own theory of causation has to some extent impaired his objectivity and reliability as an expert witness."

She blamed Poser's pet hypothesis for having set off a brush fire of litigation around the globe. At one point, U.S. court activity spurred the American Academy of Neurology to appoint a panel of specialists in an attempt to douse the conflagration and the National MS Society in 2003 was forced to weigh in, too.

"This theory only had a life in the courtroom," Mehl insisted. "He created the theory and gave evidence all over the world. That's why a lot of claims were brought and settlements were made."

It was cheaper for insurance companies to settle than go to court and risk that a judge would consider the medical evidence but still back an injured individual also suffering the debilitating effects of MS. That will change.

Besides listening to international authorities, Cullen reviewed more than 100 reports, studies and medical articles. His conclusion should put an end to litigation based on the belief minor trauma can exacerbate MS.

Lawyers in this case say dispelling Poser's opinion and aura was difficult and expensive.

That is in part because he was doing exactly what scientists are supposed to do -- posit a theory and examine the evidence. And, as you might expect, he enthusiastically and passionately defended his ideas.

But what is useful in one profession can disrupt another.

Poser's curiosity and conjecture were fine in the lab; in the courtroom, his research and analysis muddied the waters of liability by raising the rare possibility of causation. Cullen clarified the issue.

"This is the first case in Canada to really go into this situation in depth," said Robert Hartshorne, a lawyer for the defence. "It is the first North American case which analyses what has occurred here medically and it should put an end to these suits. You couldn't afford to do this every time this allegation came up. We brought in experts from the U.S., England, around the globe."

Opposing counsel Ronald Nairne agreed: "ICBC drew a line in the sand and threw everything at this. And they did very, very well. There were a number of cases like this out there and they won't proceed now."

This case has its roots in a minor fender-bender at the entrance to the SkyTrain parking lot on 10th Avenue on May 22, 1998. Both cars were only slightly damaged and were driven from the scene.

Later, driver Harris Taylor reported that as a result of the bump, she had strained the muscles in her right arm, suffered a twinge in her lower mid-back, and experienced a bit of agitation in her right shoulder. She had a history of lower-back problems.

On Sept. 8, 1998, she was diagnosed with MS at Vancouver General Hospital. The advanced stage of the disease supported the conclusion that it had been latent for some years before the accident. Nevertheless, at that time, there was a noisy debate over the controversial theory first proposed by Poser in the 1980s -- that minor trauma, whiplash or seemingly insignificant head injuries could bring on or exacerbate MS.

Back then, there was contemporaneous litigation under way in Australia, the U.S. and the U.K.

Nairne said a B.C. colleague had successfully handled a similar case here in 1995 that was settled out of court. It was thought Taylor had a similar claim that could be successfully pursued. She sued the owners of the other car -- Linda and Timothy Liong -- for more than $3 million in damages, most of which was associated with the MS claim.

At issue was whether, on a balance of probabilities, trauma could alter the natural course of the multiple sclerosis, and the lawsuit was fought as a "test case."

To answer the question, Justice Cullen embarked on a lengthy voir dire -- a trial within a trial --to determine the admissibility of expert evidence about the possible causal connection between trauma, including mild head trauma or whiplash injury, and the onset of symptomatic MS. He chose to hear specialists from both sides.

Surprisingly, Cullen was guided in his reasoning by a legal decision made in Scotland about the time this well-aged action was launched.

In that 1998 ruling on a similar suit, judge Lord Rodger concluded: "I do not find it proved, on a balance of probabilities, that trauma in general, or whiplash injury in particular, can trigger the onset of symptomatic MS . . . . I am not satisfied that whiplash injury can ever cause the onset of symptomatic MS."

Though it didn't bind him, Cullen found the reckoning behind the ruling "compelling by its lucid, careful and thorough analysis and conclusion. The fact that since that decision was pronounced (but not because of it) the relevant scientific community can be seen as coalescing around the scientific proposition that no causal relationship exists between trauma and MS symptoms in light of additional studies and discoveries, can only lend weight to the guidance implicit in Lord Rodger's extensive judgment."

Referring to study after study, Cullen averred: "All represent an erosion of support for the theory of a causal link between trauma and MS symptom onset within the medical world."

The idea that trauma could trigger the onset or exacerbation of MS symptoms is not a novel theory in the sense of being new. Researchers since at least the 1930s had suggested a link between an injury and the disease. Poser, however, had become its primary advocate -- the last man standing, if you will.

In 1999, the therapeutics and technology assessment sub-committee of the American Academy of Neurology published a "special article" written by a blue-ribbon panel that included Dr. William Sibley of the University of Arizona, Dr. George Ebers of the University of Western Ontario and Dr. Douglas Goodin, director of the MS Center at the University of California, San Francisco Medical Center. All of them testified before Justice Cullen.

Dr. Goodin said that the subcommittee was formed to conduct an assessment of the association between trauma and MS onset or exacerbation in response to a person who "felt that this [issue] was being misused in the courtroom."

Subsequently, in 2003, the National MS Society published its position referencing the AAN article and two separate epidemiological studies:

"Both studies showed that there are more traumatic events among people with MS than in the healthy control group. Many traumas were caused by MS symptoms such as incoordination, impaired balance, or abnormalities with gait or vision. These events, however, were not precipitating factors in the onset or exacerbation of the disease."

Recent medical texts also reflect that view: a complete reading of the literature provides no direct evidence in support of the hypothesis that trauma influences the expression or natural history of multiple sclerosis. Justice Cullen found the consensus compelling:

"I find that the likelihood of a causal connection between trauma and MS exacerbation is significantly less than that of a coincidental connection, in light of all the evidence adduced, and the opinion of a substantial majority of the scientific community. I thus conclude that even on a robust and pragmatic view of the evidence, it does not support proof of a causal connection between mild trauma, including whiplash, and MS exacerbation, on a balance of probabilities."

Which might put an end to the controversy in the courtroom, but it should do nothing to deaden the curiosity and enthusiasm of medical researchers -- no matter how esoteric or eccentric.

imulgrew@png.canwest.com

WHAT IS MULTIPLE SCLEROSIS?

B.C. Supreme Court Justice Austin Cullin provided the following sketch in his judgment of multiple sclerosis and its effects:

Multiple sclerosis is believed to be an autoimmune disease and that in North America, about one out of 1,000 people will be diagnosed with the affliction.

Another one in 1,000 will go undiagnosed despite having the condition.

Women were historically at double the risk of men.

Surprisingly and somewhat alarmingly, that ratio has changed dramatically (by an increase in incidence among women, rather than a decrease among men) in the past 50 years.

This strongly suggests environmental factors at play.

MS is characterized by the appearance of patches of inflammation associated with demyelination (loss of fatty insulation of nerve fibres) in the white matter of the brain, brain stem, optic nerve and spinal cord.

These patches, also called plaques or simply lesions, often occur in crops and they cause the common symptoms -- visual loss, double vision, numbness and/or weakness of the limbs.

The advent of magnetic resonance imaging (MRI) in about 1985 greatly aided researchers.

There is believed to be a strong genetic influence on the development of MS as studies have shown a relatively high correlation among family members.

Though environmental factors are also believed to be involved, they are as yet largely unidentified.

As to the triggers of the disease, epidemiological studies implicate viral infections as potential triggers in roughly 25 per cent of the cases.

There is no general acceptance of what other triggers may be responsible for the remaining 75 per cent of MS onset or exacerbation.

About Me

Cary J. Polevoy holds M.B.A and undergraduate degrees from Michigan State University. An active investor since 1965, Mr. Polevoy began his investment career as a stockbroker. He has also been a NYSE Supervisory Securities Analyst, director of research, mutual fund portfolio manager, and CEO/CFO of various small companies.
He has worked for Merrill Lynch, EF Hutton, RAC Advisors, Quantum Fund, The Broe Companies, McKinley Medical, among others.
Diagnosed with multiple sclerosis in 1995, he is the author of the book, "MS TOOLKIT - THE PATIENTS' & CAREGIVERS' GUIDE TO MULTIPLE SCLEROSIS."
DISCLAIMER: While I used to be a securities analyst, portfolio manager and registered investment advisor, I no longer am. Any opinions expressed herein are personal opinions and are not expressed as recommendations, advice or bets.